ApolloTMRecalls & reported problems across all models

We found 2 models of ApolloTM by Micro Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 98 adverse event reports in the FDA's MAUDE database, received between Dec 3, 2018 and Dec 10, 2025 — classified as 30 injuries, 68 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (30 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ApolloTM problems

ApolloTM models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ApolloTM 105-5096-000

  Agent, injectable, embolic
  64 reports
• ApolloTM 105-5095-000

  Agent, injectable, embolic
  34 reports

Recent ApolloTM adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Difficult to Remove; Retraction Problem; Detachment of Device or Device Component; Difficult to Remove; Retraction Problem; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE APOLLO CATHETER AUTO DETACHED BY ITSELF BEFORE ONYX COMPLETELY INJECTED. IT WAS REPORTED THE APOLLO CATHETERS TIP PRE-DETACHED. THIS OCCURRED DURING ONYX INJECTION. THE PHYSICIAN HAD A CONTINUOUS INJECTION. THE INJECTION WAITING TIME WAS 2 MINUTES. THERE WAS NO ONYX REFLUX. THE PATIENT WAS UNDERGOING AN EMBOLIZATION FOR AN ARTERIOVENOUS MALFORMATION. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767414 ↗
• InjuryDec 9, 2024Difficult to Remove; Stretched; Difficult to Remove; Stretched

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STABLE, NO BETTER OR WORSE. THE PATIENT EXPERIENCED ISCHEMIA IN A FEW LOCATIONS. THE VESSEL OCCLUSION WAS TREATED LIKE A STROKE. ASPIRATION AND SFR WAS USED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Ischemia Stroke; Rupture

  MAUDE report 20882909 ↗
• MalfunctionOct 18, 2024Break; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT CATHETER TIP OF THE APOLLO DROPPED OFF PREMATURELY. THERE WAS CATHETER SEPARATION/BREAK IN THE DISTAL SECTION DURING USE. THERE WAS FRICTION OR DIFFICULTY DURING INJECTION. THERE WAS FORCE APPLIED DURING DELIVERY OR REMOVAL. THE CATHETER TIP WAS NOT ENTRAPPED/STUCK. THERE WAS NO VASOSPASM. THE CATHETER WAS NOT STUCK INSIDE THE GUIDE CATHETER. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE BROKEN SEGMENTS, DISTAL 1.5 CM OF APOLLO, REMAINS IN THE PATIENT IN THE MIDDLE MENINGEAL ARTERY (MMA). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR MMA TREATMENT. THE MMA WAS THE ACCESS VESSEL WITH A DIAMETER OF 2MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20486810 ↗
• InjuryAug 12, 2024Detachment of Device or Device Component; Difficult to Advance; Physical Resistance/Sticking; Detachment of Device or Device Component; Difficult to Advance; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED AFTER THE PROCEDURE THE PATIENT IS DOING GREAT AND IS BACK TO BASELINE. ONYX WAS NOT USED WITH THE CATHETER. THE CAUSE OF THE DETACHMENT WAS RESISTANCE IN THE WIRE AND VESSEL FROM SPASM. APOLLO TIP CAME OFF BEFORE THEY TRIED TO RETRIEVE IT. THEY WERE STILL NAVIGATING TO THE ARTERIOVENOUS MALFORMATION (AVM). THE HEALTH CARE PROVIDER (HCP) PLANS TO BRING THE PATIENT BACK AND TREAT THEY AVM FOR SURGERY AND RETRIEVE THE CATHETER TIP. THE LOCATION OF THE TIP IS THE EXTERNAL CAROTID BRANCH. THERE WAS NO VESSEL CALCIFICATION. THE WAS NO DAMAGE NOTICED TO THE DEVICES.

  Patient problems: Foreign Body In Patient; Vasoconstriction

  MAUDE report 19961739 ↗
• MalfunctionJan 3, 2024Burst Container or Vessel; Device Damaged by Another Device; Burst Container or Vessel; Device Damaged by Another Device

  ADDITIONAL INFORMATION RECEIVED REPORTED ONYX WAS NOT USED. THE EVENT WAS NO ASSOCIATED WITH ONYX; NONE HAD BEEN INJECTED. NO CATHETER FRAGMENTS WE LEFT IN THE PATIENT'S BODY. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. NO IMAGES WERE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18436194 ↗
• MalfunctionDec 12, 2023Compatibility Problem; Physical Resistance/Sticking; Compatibility Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHILE DOING THE EMBOLIZATION OF A COMPLEX RUPTURED ARTERIOVENOUS MALFORMATION (AVM)  WITH ONYX-18 LES, THE PHYSICIAN PLACED THE APOLLO MICROCATHETER AT THE OPTIMUM POSITION INSIDE THE NIDUS. THEN AFTER INJECTING APPROXIMATELY 0.25ML. OF THE ONYX-18, THE PHYSICIAN REALIZED THAT IT WAS NOT COMING OUT FROM APOLLO <(>&<)> RESISTANCE WAS INCREASING. SO THE PHYSICIAN HAD TO TAKE OUT THIS APOLLO MICROCATHETER <(>&<)> ONYX-18 SYRINGE <(>&<)> USED NEW MICROCATHETER TO COMPLETE THE EMBOLIZATION PROCEDURE. WHILE TAKING OUT THE ATTACHED ONYX SYRINGE, SOME ONYX WAS DROPPED ON THE OPERATING TABLE.  THE ONYX AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE APOLLO WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.  THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AVM. THE AVM IS AN ELOQUENT REGION. THE ACCESS VESSEL WAS THE RIGHT POSTERIOR INTERNAL CAROTID ARTERY WITH A DIAMETER OF 1.2MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. ADDITIONAL INFORMATION RECEIVED REPORTED THE DEAD SPACE OF 0.23ML. WAS FILLED WITH DMSO. DURING FLUSHING THER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311251 ↗
• MalfunctionNov 3, 2023Break; Leak/Splash; Break; Leak/Splash

  MEDTRONIC RECEIVED A REPORT THAT AFTER THE PHYSICIAN SELECTED THE TARGET VESSEL, A CONTRAST RUN WAS DONE AND IT WAS NOTICED THAT CONTRAST WAS SEEPING OUT OF THE SIDE OF THE APOLLO CATHETER. NOTHING WAS COMING OUT OF THE DISTAL END BECAUSE THERE WAS A HOLE/TEAR IN THE DISTAL THIRD OF THE APOLLO. THE APOLLO AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE APOLLO WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.   THE PATIENT WAS UNDERGOING SURGERY FOR A PRE-SURGICAL ARTERIOVENOUS MALFORMATION (AVM) EMBOLIZATION OF THE MIDDLE CEREBRAL ARTERY (MCA) AVM. THE ACCESS VESSEL WAS THE LEFT MCA WITH A DIAMETER OF 2MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18064335 ↗
• MalfunctionOct 6, 2023Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS BEING TREATED WITH ONYX LES FOR A DURAL ARTERIOVENOUS FISTULA (DAVF) (OFF LABEL). THE DOC WAS GOING UP THE LEFT EXTERNAL CAROTID AND INTO THE MIDDLE MENINGEAL ARTERY (MMA) THEN NOTICED THE CATHETER HAD DETACHED (PRIOR TO THE DETACHABLE TIP). NO ONYX WAS PUSHED YET. THIS WAS AT THE BEGINNING OF THE CASE. THERE WAS CATHETER SEPARATION/BREAK DURING USE. THERE WAS NO FRICTION OR DIFFICULTY DURING INJECTION. THERE WAS NO FORCE APPLIED DURING DELIVERY OR REMOVAL. THE CATHETER TIP WAS NOT ENTRAPPED OR STUCK. THERE WAS NO VASOSPASM. THE CATHETER WAS NOT STUCK INSIDE THE GUIDE CATHETER. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE BROKEN LOCATION WAS DISTAL. THE BROKEN SEGMENTS (4-5CM) REMAIN IN THE PATIENT'S LEFT MMA. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF DURAL AV FISTULA WITH ONYX (OFF-LABEL.) IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE LEFT EXTERNAL CAROTID AND MMA. ANCILLARY DEVICES INCLUDE A BENCHMARK 6FR 95CM (LOT # F00007811) GUIDE CATHETER, VECTA

  Patient problems: Foreign Body In Patient

  MAUDE report 17890282 ↗
• MalfunctionOct 4, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT THAT THE APOLLO BROKE AT THE DETACHMENT ZONE AS THE DOCTOR WENT UP TO THE M3 SEGMENT DURING A PRE-OP EMBO OF AN OCCIPITAL ARTERIOVENOUS MALFORMATION (AVM). HE NOTICED THE CATHETER HAD DETACHED AFTER DOING HIS MICRO RUN THROUGH THE CATHETER. THE APOLLO CATHETER BROKE OFF BEFORE TIP. THERE WAS NO FRICTION OR DIFFICULTY DURING INJECTION. THERE WAS NO FORCE APPLIED DURING DELIVERY OR REMOVAL. THE CATHETER TIP WAS NOT ENTRAPPED OR STUCK. THERE WAS NO VASOSPASM. THE CATHETER WAS NOT STUCK INSIDE THE GUIDE CATHETER. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THE DISTAL PORTION WAS BROKEN. MULTIPLE PEDICLES WERE EMBOLIZED AFTER THIS EVENT. PATIENT WAS SCHEDULED FOR RESECTION THE NEXT DAY AND NO SUBSEQUENT ISSUES WERE REPORTED. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR PRE-OP EMBO FOR BRAIN AVM. THE ACCESS VESSEL WAS THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. ANCILLARY DEVICES INCLUDE A 6FR FUBUKI XF SHEATH (FBKX-8S80DY) LOT # 220709C421 SHEATH, NAVIEN 058 115CM RFX058-115-08 LOT

  Patient problems: Foreign Body In Patient

  MAUDE report 17870872 ↗
• MalfunctionSep 20, 2023Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE APOLLO BROKE IN THE MIDDLE WHILE DOING THE PROCEDURE. THE BROKEN PIECES ARE BEING RETURNED. THE APOLLO AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE APOLLO WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A MIDDLE MENINGEAL ARTERY (MMA) ANEURYSM. THE ACCESS VESSEL WAS THE MMA WITH A DIAMETER OF 1-2MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785380 ↗
• InjuryAug 1, 2023Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  ADDITIONAL INFORMATION WAS RECEIVED THAT TIP DETACHMENT OCCURRED DURING NAVIGATION THROUGH THE GUIDE CATHETER. THERE WAS NO RESISTANCE WHEN THE APOLLO WAS BEING RETRIEVED AND THERE WAS NO RETRIEVING ATTEMPTED. THE APOLLO TIP WAS NOT EMBEDDED IN THE ONYX CAST AS EMBEDDING IN ONYX HAD NOT STARTED YET. THE CATHETER TIP COULD NOT BE RETRIEVED AND IS IN THE EXTERNAL CAROTID ARTERY. THERE WAS NO NOTE OF VESSEL CALCIFICATION. THERE WAS NO KINK OR DAMAGE NOTED ON ANY OF THE DEVICES.

  Patient problems: Device Embedded In Tissue or Plaque; Obstruction/Occlusion

  MAUDE report 17433853 ↗
• InjuryJun 14, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS RESISTANCE WHEN THE APOLLO WAS BEING ADVANCED: ANTERIOR CEREBRAL 2 BRANCH (A2). WHEN THE DEVICE WA BEING RECEIVED THE TIP WAS DETACHED WITH NO RESISTANCE. THE APOLLO TIP WAS NOT EMBEDDED IN THE ONYX CAST. IT WAS NOTED THAT THERE MAY BE FUTURE PLANS¿TO RETRIEVE THE CATHETER TIP. THE ANATOMICAL LOCATION OF THE APOLLO TIP: A2. THERE WAS NO NOTE OF VESSEL CALCIFICATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17125468 ↗
• InjuryJun 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT RECOVERED WELL AFTER THE OPERATION. THERE ARE NO PROCEDURAL / POST-PROCEDURAL IMAGING (CT ,ANGIO, ETC.) AVAILABLE. THE ACTIONS/INTERVENTIONS TAKEN TO RESOLVE THE PREMATURE TIP DETACHMENT INCLUDED PUSHING THE TIP END THAT HAS BEEN DETACHED PREMATURELY TO THE PART TO BE GLUED. THE PROCEDURE WAS COMPLETED BY PUSHING THE TIP END THAT HAS BEEN DETACHED PREMATURELY TO THE PART TO BE GLUED; REPLACED WITH NEW APOLLO GLUE. THE TIP DETACHMENT OCCURRED DURING NAVIGATION THROUGH THE GUIDE CATHETER. THERE WAS NO RESISTANCE WHEN THE APOLLO WAS BEING ADVANCED. THERE ARE NO¿FUTURE PLANS TO RETRIEVE THE CATHETER TIP. THE ANATOMICAL LOCATION OF THE APOLLO TIP IS IN THE M2. THERE WAS NO NOTE OF VESSEL CALCIFICATION. THERE WAS NO KINK OR DAMAGE NOTICED ON ANY OF THE DEVICES.

  Patient problems: Foreign Body In Patient

  MAUDE report 17117156 ↗
• MalfunctionMay 23, 2023Compatibility Problem; Physical Resistance/Sticking; Compatibility Problem; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT AN APOLLO CATHETER WAS OCCLUDED DURING ONYX INJECTION. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ARTERIOVENOUS MALFORMATION. THE ACCESSED VESSEL WAS TO FEMORAL ARTERY WITH A DIAMETER OF 5 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT IN THE TREATMENT OF ARTERIOVENOUS MALFORMATION, THE OPERATOR USED DETACHABLE APOLLO CATHETER TO INJECT NEW OSCILLATING ONYX. AT THE END OF THE CATHETER, IT WAS DIFFICULT TO INJECT AND THE CATHETER WAS BLOCKED, SO A NEW CATHETER WAS REPLACED AND THE OPERATION WENT SMOOTHLY. IT WAS REPORTED THERE WAS CATHETER RESISTANCE IN THE DISTAL SECTION OF THE CATHETER. IT WAS ALSO REPORTED THERE WAS CATHETER OCCLUSION DURING THE ONYX INJECTION. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE ANATOMICAL LOCATION OF THE AVM WAS THE INTRACRANIAL OCCIPITAL LOBE. THE DEAD SPACE OF THE DELIVERY CATHETER WAS FILLED WITH DMSO. THERE WAS NO FRICTION OR DI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16988827 ↗
• MalfunctionMay 3, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL TIP OF THE APOLLO CATHETER WAS KINKED AND DAMAGED. THE DEVICE WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR AN ARTERIOVENOUS MALFORMATION (AVM). THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WHICH WAS 8.5MM IN DIAMETER. ANCILLARY DEVICES INCLUDE ONYX LIQUID EMBOLIC. ADDITIONAL INFORMATION RECEIVED THAT THERE WERE NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16861576 ↗

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